NCT07121309

Brief Summary

The aim of this study is to construct a predictive model for postoperative delirium in elderly patients with hip fractures. The main question it answers is to construct a risk prediction model for hip fractures in the elderly through six machine learning methods, compare which method's model is better, and conduct external validation of the model's stability to provide a reference for the early clinical detection of postoperative delirium in elderly hip fracture patients. The clinical data of elderly patients with hip fractures have been collected in clinical practice and the model has been constructed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
901

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 6, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

Hip fracturePrediction model

Outcome Measures

Primary Outcomes (1)

  • Postoperative delirium

    The Memory and Delirium Assessment Scale (MDAS) was used for delirium risk screening and assessment, including consciousness, attention, speech, behavior, and sleep aspects.

    The day after the operation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over 60 years old who undergo surgical treatment for hip fractures

You may qualify if:

  • Age ≥ 60 years; diagnosed with hip fracture by X-ray; patients who underwent surgical treatment.

You may not qualify if:

  • Patients with other severe diseases (Patients who reach grade IV or higher according to the American Society of Anesthesiologists (ASA) health status classification;Suffer from end-stage diseases;there is multiple organ dysfunction syndrome (MODS) or single organ failure); patients with mental disorders; patients participating in other studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SecondSoochowU

Suzhou, Jiangsu, 215004, China

Location

MeSH Terms

Conditions

DeliriumHip Fractures

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 13, 2025

Study Start

October 17, 2024

Primary Completion

March 3, 2025

Study Completion

March 3, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations